System and devices for the repair of a vertebral disc defect

ABSTRACT

A system for repairing a vertebral disc defect, such as hernia or bulge, a full or partial tear in the annulus, or a weakened annulus wall as a result of an excision procedure. The system introduces a treatment device arranged to repair the defect, and may prevent the leakage of fluid from the nucleus. The components of the device may be resorbable materials, and may induce the ingrowth of cellular material into the components. The system may feature a locating device to ensure proper placement of the treatment device.

FIELD OF THE INVENTION

The invention relates generally to methods and devices for humansurgery, and in particular these methods and devices may be useful forspinal surgery. More particularly, certain embodiments of the inventionrelate to devices and methods for treating injuries, defects or surgicalprocedures associated with the intervertebral disc.

BACKGROUND OF THE INVENTION

Injuries to the human spine and subsequent pain are one of the mostprevalent debilitating conditions affecting the human population. Formany of those affected, no position can ease the pain or discomfortassociated with spinal injuries or deformities. Such spine related paincan lead to decreased productivity due to loss of work hours, addictionto pain-killing drugs, emotional distress, and prolonged hospital stays.The economic impact of such problems is significant. One common causefor many instances of chronic pain is the bulging, or herniation of theintervertebral disc.

The intervertebral disc is made of two parts, a tough collagen outerlayer, known as the annulus fibrosus (hereinafter also referred to as“AF” or “annulus”), and a soft central core known as the nucleuspulposus. The annulus fibrosus is composed of numerous concentric ringsor layers of fibrocartilaginous tissue. Fibers in each ring crossdiagonally, and the rings attach to each other with additional radialfibers. The rings are thicker anteriorly (ventrally) than posteriorly(dorsally). The nucleus pulposus (hereinafter also referred to as “NP”or “nucleus”) is a gelatinous material, which forms the center of thedisc. The discs tend to vary in size and shape with their position inthe spine. The nucleus pulposus is composed of a loose, nonoriented,collagen fibril framework supporting a network of cells resemblingfibrocytes and chondrocytes. This entire structure is embedded in agelatinous matrix of various glucosaminoglycans, water, and salts. Thismaterial is usually under considerable pressure and is restrained by theannulus.

A tear or weakening in the layers of the annulus fibrosus portion of thedisc can allow the soft center portion of the disc (the nucleus) to leakout of the annulus, alternatively, the weakened annulus may simplybulge. A ruptured disc may allow the leaking nucleus propulsus materialto press up against a spinal nerve root or spinal cord, causing pain,numbness, tingling and/or weakness in a person's extremities. Herniateddiscs may occur at any level of the spine, but are more common in thelumbar area, followed in frequency of occurrence by the thoracic regionand cervical region. Weakening or tearing of the annulus fibrosus mayalso result in bulging of the annulus fibrosus due to pressure of thenucleus pulposus against the annulus. The bulging tissue may alsoimpinge upon the nerve root or spinal column, causing pain.

The traditional surgical method for treating a damaged, bulging, orherniated disc involves tissue removing procedures to relieve theimpingement of the annulus fibrosus or the nucleus pulposus from thesurrounding nerves. The procedure is commonly known as a discectomy, andconsists of the removal of at least a portion of the disc; it may beperformed in an open procedure, a minimally invasive procedure, or anendoscopically assisted procedure. These procedures generally result ina large defect of the annulus fibrosus and in a certain percentage ofcases, may lead to progressive degradation of the disc, both nucleuspulposus and annulus fibrosus, lysthesis of adjacent vertebral bodies,stenosis of the nerve canals and increases in related pain symptoms. Ameans of mechanically and/or biologically repairing the annulus fibrosusmay delay or prevent this degeneration cascade of the disc.

Newer technologies and procedures, such as nucleus replacement withinjectable or solid prosthetic nucleus devices may also result in abreach in the otherwise coherent annulus fibrosis. In these cases, it isdesirable to mechanically close, or otherwise repair the defect in theannulus created to insert the prosthetic material and prevent suchmaterial from leakage and extravasation.

The annulus fibrosis (AF) of the intervertebral spinal disc is alamellar configuration of collagen layers intended to maintain the softviscous internal nucleus propulsus (NP), provide for motion and linkageof the adjacent vertebral bodies (VB). Certain degenerative orpathologic changes may occur either within the NP which can lead to overstress of the AF and subsequent damage to or tearing of the AF. If leftuntreated, herniation of the NP may occur, most importantly, theherniation may progress posteriorly toward the spinal cord and majornerve roots. The most common resulting symptoms are pain radiating alonga compressed nerve and low back pain, both of which can be crippling forthe patient. The AF may also be torn through traumatic injury, which canlead to progressive degenerative changes and herniation or ultimatelylisthesis of the adjacent VB.

Herniation may be caused by, or be the result of weakening in the AF.Secondary to physiologic changes of the AF or NP, the AF may weaken andprotrude from its normal anatomic space, similar to an air bubble bulgein a car tire, or in more severe cases, the AF may tear and allowextravasation of the NP contents to the surrounding anatomy. Symptomsmay arise when the herniation or leakage of the NP impinges on the nerveroot or spinal cord. There are therapies currently utilized fortreatment of the herniation of a vertebral disc, and the resultant pain,starting with conservative therapies such as bed rest and painmedicines, to more invasive therapies, such as epidural injections, openor minimally invasive discectomies or aggressive therapies, such ascomplete discectomy and fusion of the disc space and adjacent vertebrae.

The prior art describes various procedures and devices for repairingdamage to the vertebral disc. The prior art describes repairing aherniated disk by various means, including prosthetic implants, andstressed members. For example, in U.S. Pat. No. 6,805,695, Keith et al.disclose devices and methods of reinforcing an annulus of the disc byintroducing a circumferential reinforcement member around the annulus ofthe disc, or through the annulus and nucleus of the disc.

In U.S. Pat. No. 6,371,990, Ferree discloses an apparatus and method forrepairing annular tears and the prevention of further annular tears.Ferree seeks to control vertebral motion by augmenting the annulus withan implant, thereby minimizing the opportunity for annular tears. Theaugmenting implant is described as being a mesh that may be stapled intothe interior of the annulus.

Ferree also discloses in U.S. Patent Application 2004/0097980 anexpandable material to fill a defect in a disk, and that the materialmay be anchored to the annulus with respect to the void filled. In anembodiment, the anchors are described as penetrating through the outerwall of the disc and serve to hold the flexible implant material inplace.

Yeung discloses in U.S. Pat. No. 6,530,933 a method and apparatus forherniated disc repair using resilient fastener elements that areimplanted and spring back to an original shape to apply tension throughgripping elements to hold tightly to the annulus. In an alternativeembodiment, the annulus repair technique utilizes a suture affixed to adumbbell shaped rod to serve as an anchor. The anchor is placed againstthe outside surface of the annulus, and the suture extends across theinterior of the vertebral disc through the nucleus propulsus and out theother side of the disk, such that tension may placed against the disc torepair the hernia, and the tension may be maintained through the use ofa washer and suture locking element, such as a knot. With thisalternative embodiment, a sealing material may optionally be placedunderneath the washer.

In U.S. Pat. No. 6,592,625, Cauthen describes annular repair orreconstruction by insertion of a collapsible patch into the subannularspace, whereupon the patch expands to fill the gap and seal off theopening from the escape of nucleus material. Cauthen describes hisdevice as being useful to restore integrity after damage or discectomyto alleviate a herniated vertebral disc; Cauthen does not obviate theneed for the discectomy procedure to repair a herniated disc.

In U.S. Pat. No. 6,224,630, Bao describes the repair of anintervertebral disc using an expandable porous material that is insertedinto an aperture, and subsequently becomes more permanently secured asthe ingrowth of tissue into the pores is actively facilitated. Baocreates a device having a tamponade effect where the swelling of thematerial provides securement and does not describe a more securemechanical anchorage using a rigid component in combination with atissue regenerative material.

The prior art also describes various methods for sealing a percutaneousclosure, for example, Kensey et al. in U.S. Pat. No. 5,545,178 describea system for sealing a puncture made through skin and having a tractextending through to underlying tissue. The puncture closure systemconsists of an anchor introduced into the underlying tissue and having afilament attached thereto, the filament extends out from the puncture,and facilitates the introduction of a plug material into the tract,whereupon tension is maintained through the use of a holding member.Kensey et al. does not describe the sealing of multiple sites throughthe employment of a single device, nor is the employment of multipleanchors or plugs on a single filament described.

The prior art does not describe a device wherein the device may becapable of being implanted arthroscopically, among other methods knownin the art, and is arranged to prevent the escape of nucleus propulsusfrom a defect in the annulus, while providing supporting and securedsealing means in a single device, and the device may be capable ofpreserving normal annulus geometry.

Accordingly, there is a need for a device capable of meeting these andother objectives, wherein the device provides support and secure sealingmeans for a defect as well as the ability for cellular infiltration andsubsequent repair occurring in or created in the annulus fibrosis.Furthermore, there is a need for a device capable of preserving orrestoring normal annulus geometry (e.g., repairing a herniated disc),wherein there is support and secured sealing provided at each point ofpenetration or defect in the annulus.

It is the intent of this invention to overcome these and othershortcomings of the prior art.

SUMMARY OF THE INVENTION

Various embodiments of the current invention strive to overcome thesevarious shortcomings in the prior art. These embodiments allow forsingular devices, or combinations of anchors or fastening devices whichprovide support for the annulus, while sealing the annulus, restoring ormaintaining satisfactory disc geometry and providing the scaffold forregeneration of the damaged annulus.

Certain of these embodiments have anchors which may be deployed on bothsides of the annulus wall, thereby creating and exerting pressure on thewall. This pressure alone may serve to support and/or seal the annulus;however, the anchors themselves may feature or further be utilized incombination with a sealing means (e.g., elastic biomaterials, patches,collagen, etc.) that may be beneficial or necessary to aid sealing. Thevarious embodiments of the invention contemplate the use of a variety ofdevices including, but not limited to, patches, plugs, staples,expandable materials, meshes, anchors, sutures, flowable materials,sealants, glues, gels and other wound and tissue repair devices known inthe art.

Several embodiments of the present disclosure utilize at least onesealing means. The sealing means, or sealing member, as the terms areused interchangeably herein, may be most beneficial if placed at theinside wall of the annulus or on the outside of the wall depending onthe geometry of the device, the type of sealing means, and the geometryof the affected anatomy. Furthermore, the seal may be placed proximal ordistal to the fastening device(s). It is recognized that the forceinternal to the annulus (i.e., the force from the fluid nucleuspropulsus) may assist sealing by pressing the sealing means against theannulus, where such sealing means may be preferably located internal tothe annulus.

Overall disc or annulus geometry may be beneficially altered by placinga fastening device at or through a distal wall of the annulus, whileplacing a second fastening device at or through the proximal wall, wherethe devices are connected, e.g., by a tether, suture, flexible, or rigidmember. This type of device would allow compression to be placed acrosseach disc wall, while simultaneously compressing or restraining the discacross its diameter. Again, sealing means may be employed, as previouslydiscussed.

These various embodiments may be particularly useful in the situationwhere the annulus is torn. Since the annulus is fibrous, tears generallyoccur in the circumferential direction (i.e., not purely radial) alongat least a portion of the fibers. Deploying a fastening device acrossthe tear could cause compression to be placed across the torn annulussurfaces, thereby allowing the combination of securement and friction(thereby restricting movement of the torn surfaces against each other)to hold and support the annulus.

Commonly, discectomies or laminectomies are performed to relieve pain.These embodiments may augment, if not replace these types of procedures.That is, multiple fasteners, or a single through-wall fastener, may beplaced proximal and distal to the annulus entry tract (in the case of adiscectomy), and a sealing patch may be placed adjacent either fastener,or the sealing patch may reside mid-wall to the annulus.

It is also recognized that a sealing member may function as a fasteneritself, thereby minimizing the number of device components, proceduralsteps, and/or procedural time. To that end, a sealing member may berigid, compliant, or elastic; furthermore, the sealing member may be acomposite of various materials, which are best suited for support andsealing functions. As a non-limiting example, such fasteners may becomprised of a rigid polymeric backing material (which may or may not beresorbable, e.g., PLA or polyurethane) which has a layer that contactsthe tissue which comprises a malleable material, which may or may not beresorbable (e.g. polymer, collagen, etc.) to seal the tear orprocedurally made opening. Such components may be comprised of materialsinherently radiopaque or treated with substances which make themradiopaque when viewed under standard imaging techniques to allow thesurgeon to visualize placement.

These various embodiments may be at least partially made from permanentor biodegradable materials such as those listed in Table 1, and thesedevices may have a secondary or tertiary effect by the delivery of drugsor biologics such as those listed in Table 2. In an embodiment of afastening or sealing device made from the materials described above,once implanted in a living being, the device may cause or induce the newgrowth or regrowth of cellular material. In this embodiment, thematerial encourages the ingrowth of cellular material that securelyintegrates the device into the surrounding tissues, thereby repairingthe weakened area in a more effective manner.

In the embodiment where the device is a resorbable material, theingrowth of cellular material into the device allows for a permanentrepair upon complete resorption of the resorbable device, as thematerial is replaced by the growth of cells to create a natural tissuematerial similar to and integrated with the surrounding structures.

In the embodiment where the device is a non-resorbable material, theingrowth of cellular material into the device allows the completeintegration of the device with the surrounding tissue, thereby creatinga suitable repair having nearly similar compliance and other physicalcharacteristics as the original tissue material.

Procedurally, these various embodiments may be delivered from posterioror anterior directions, based on the anatomical constraints as well as,among other things, hermiation, disease, or type and geometry of thedefect. While it is envisioned that similar, if not the same, deliverydevices and methods may work for posterior as well as anteriorprocedures and placements, certain types of procedures may benefitgreatly from devices or embodiments which sense their location or detectwhere they are located in the anatomy. For many annulus repair devicesit may be beneficial to utilize minimally invasive methodologies toposition the device. Minimally invasive procedures utilize laproscopicor endoscopic instruments to perform procedures through small openingsin a patient's skin and can result in less trauma and faster healingtimes for the patient. However, such approaches are challenging in thatthe physician may not be able to directly visualize many aspects of theprocedure. It has been discovered through experimentation in ex-vivomodels that several embodiments of the devices of this invention canbenefit by using delivery systems that can locate the transition betweenthe annulus and the adjacent tissues to ensure proper device placement.

Location detection devices are known in the art, for example U.S. Pat.No. 5,282,827, assigned to the assignee of the present disclosure, maybe used to accurately place a hemostasis device in an artery (deliveryof a hemostasis device using a location detector) also assigned to theassignee of the present disclosure. However, while these aforementioneddevices may perform suitably for the currently contemplated procedures,certain modifications could improve their performance. That is, theannulus propulsus, as well as certain of the surrounding fluid, isnormally more viscous and less able to flow to provide the “perceptiblesignal” of the aforementioned patents.

In order to improve upon these previous embodiments, the locationdetection means incorporated in the current embodiments may furthercomprise instrumentation or other features allowing for accurateplacement of the device percutaneously. Such instruments may becalibrated at some portion so as to allow the surgeon to determine theexact thickness or dimension of the spinal disc component to betraversed with the fixation device. These placement instruments can alsobe comprised of an actual depth measurement instrument whereby thesurgeon can engage the aspect of the disc to which the distal mostportion of the device should engage and then determine the traversingdistance. A location detection means may also beneficially stabilize thedelivery system for the placement of a repair device in anintervertebral disk.

DESCRIPTION OF THE DRAWINGS

FIG. 1-3. Depicts overhead cross-sectional views of a vertebral dischaving a defect therein, in the form of an annulus wall having a reducedthickness, a partial tear, and a full tear.

FIG. 4-8, and 11. Depiction of the placement of various closure ortreatment devices of the present invention.

FIGS. 9 and 10. Exemplary depiction of an anchoring member with andwithout barbs.

FIG. 12. Cross sectional depiction of a cannula and obturator for theimplementation of the present invention.

FIG. 13. Partial cross-section of embodiments of the delivery device andtreatment device of the present invention.

FIG. 14. Another embodiment of the treatment device and delivery device,housed within the access sheath.

FIG. 15. A cannula and access sheath of the present inventionincorporating a location detector means.

FIGS. 16 and 17. Depicts overhead cross-sectional views of a vertebraldisc having a defect therein, in the form of a hernia or bulge in theannulus, having an intact annulus or extravasation of the nucleus.

FIG. 18-24. Depiction of the placement of various closure or treatmentdevices of the present invention.

FIG. 25. A depiction of the components of one embodiment of thetreatment or closure device of the present invention.

FIG. 26-28. Depiction of the implanting of the treatment device of FIG.25.

FIG. 29. Depicts overhead cross-sectional views of a vertebral dischaving a nucleus implant material placed into the nucleus.

FIG. 30. A cross-sectional view of a vertebrae and disc from abovedepicting a defect in the annulus.

FIG. 31. An access cannula (e.g. needle) positioned into the defect ofFIG. 30.

FIG. 32. An exploded profile view of a cannula and obturator.

FIG. 33. An exploded profile view of a guidewire and cannula.

FIG. 34. An elevated view of the Guidewire positioned into the accesscannula and directed into the disc of FIG. 31.

FIG. 35. An elevated view of the Guidewire of FIG. 34 remaining in placeas the access cannula is removed from the patient.

FIG. 36. An elevated view of the positioning of an Access sheath overthe Guidewire of FIG. 35.

FIG. 37. An elevated view of the Access sheath of FIG. 36 as theobturator (e.g. dilator) and guidewire of FIG. 36 are removed.

FIG. 38. An elevated view of the activation or deployment of a locationdetector on the access cannula of FIG. 37.

FIG. 39. An elevated view of the retraction of the access sheath anddeployed location detector of FIG. 38.

FIG. 40. An elevated view of a deployment of a locking ring on theaccess sheath of FIG. 39.

FIG. 41. An elevated view of the access sheath of FIG. 40 and depictingthe introduction of the delivery system into the access sheath.

FIGS. 42-47. Elevated profile views of the deployment and securement ofthe closure device of the delivery system of FIG. 41.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Repair of Tears of the Annulus Fibrosis

The annulus fibrosis (AF) of the intervertebral spinal disc is alamellar configuration of collagen layers intended to maintain the softviscous internal nucleus propulsus (NP), provide for motion and linkageof the adjacent vertebral bodies (VB). Certain degenerative orpathologic changes may occur either within the NP or the AF which canlead to over stress of the AF and subsequent damage to or tearing of theAF. If left untreated, herniation of the NP may occur through the tear,and most importantly, the herniation may progress posteriorly toward thespinal cord and major nerve roots. The most commonly resulting symptomsare pain radiating along a compressed nerve and low back pain, both ofwhich can be crippling for the patient. The AF may also be torn throughtraumatic injury, which can lead to progressive degenerative changes andherniation or ultimately listhesis of the adjacent VB.

An embodiment of the present invention is intended to provide means bywhich the AF can be compressed, e.g., along, or across, as appropriate,the axis of tear, thereby preventing the potential herniation of the NPthrough the tear and resultant pain.

Any or all of the embodiments of the present invention may beneficiallyincorporate a location detection means that is capable of providing foraccurate positioning and placement of the device by sensing or otherwiseallowing the detection of the location of the device within the anatomy.More specifically, the location detection means may allow the detectionof the location of the device in order to ensure the proper placement ofthe components of the device within the annulus, nucleus, and/or theinterface between the annulus and nucleus. Additionally, the locationdetection means may also serve as a locking member to maintain aposition of at least a portion of the device with respect to the body.

Various methods disclosed herein could be used for such purposes. Oneembodiment would include the use of an expanding balloon or anarticulating wing or finger to locate the interface between the nucleusand annulus, and assure proper placement of the closure or treatmentdevice. By way of example, a delivery tube or access cannula could havean expandable or reconfigurable member (e.g. balloon, anchor, finger,etc.) that can be used to help locate the transition between the annulusand nucleus or other adjacent tissues. Such expandable members couldhelp provide an indication of proper location for device placement aswell as help to create a physical space into which a device can beimplanted. The system could be advanced into the appropriate tissue andthen the expandable or reconfigurable element could be activated, thedevice could be withdrawn, advanced, or otherwise manipulated until anindicator provides a signal that the device is at the desirablelocation. Concepts of this approach could employ “tactile feel” as oneindicator, to sense when a delivery system is at the appropriatelocation. Similarly, sensors may be utilized at or near the distal endof the device to confirm placement, such as an optical sensor orpressure sensor that may be exposed to tissue during placement of thedevice, and enable confirmation of accurate placement of the device.

It is recognized that such an expandable or reconfigurable member mayalso beneficially serve to stabilize the disc, and or the components ofthe invention during and after placement of the device. Additionally,other stabilizing components may be utilized to achieve proper placementof the device, such as a sliding ring, flange, or other component thatmay be delivered following the insertion of a delivery tube or sheath,and placed against the target site, or the surrounding tissues to lendstability to the device. As can be seen with reference to FIGS. 36-46,and to be discussed in further detail below, the expandable member maybe expanded against the annulus interior wall, thereby preventing theretraction of the positioning device from the nucleus, and stabilizingthe positioning member. Optionally, a slidable flange may be advancedalong the body of the positioning device in order to apply securingpressure against the exterior of the annulus, or other tissue, therebymaintaining the accurate placement of the positioning device. The flangemay be advanced by external application of force, or alternatively, maybe advanced by operation of an advancing mechanism, such that theslidable flange is directed towards the distal end of the positioningdevice.

In another embodiment of a location detection means, a cannula or accesssheath may be provided having a separate pathway (e.g. a lumen) forproviding a location probe. The separate pathway may have an exit portlocated at or near the distal end of the delivery system. A flexible orreconfigurable member may be extended, either through the device, orfrom the device, and allow the surgeon to gauge the nature of thetissue, such as through tactile feel. A member being inserted intonucleus propulsus material would relay tactile information that thetissue is soft, as it would easily yield to advancement of the probe. Incontrast, the tough fibrous annulus material would provide greaterresistance to the advancement of the probe, affording similarconfirmation of placement of the device.

In another embodiment, the location detection means may rely oncalibrated insertable components, such as needles, delivery sheaths, orcannulas, which may be provided having graduated markings to indicatedepth of penetration, and allow proper placement of the repairingcomponents of the device.

It is also recognized that the use of markers or bands (e.g.radiographic markers, visual markers, etc.) may provide locationinformation for any of the described embodiments, such as through theuse of radiographic techniques (e.g. MRI, X-ray, etc.), and further aidin ensuring the proper placement of the device of the present invention.

FIG. 1 shows a transverse section of the intervertebral disc spacebetween two adjacent vertebral bodies. The intervertebral disc 16contains the annulus fibrosis (AF) 3, which surrounds a central nucleuspropulsus (NP) 4. Also shown in this figure are the spinal cord 1 andthe nerve roots 2. In FIG. 1, the annulus is depicted having a defect 9therein, wherein the thickness of the annular wall is reduced, as mayoccur through, for example, a full or partial discectomy procedure,where the removal of at least a portion of the annular wall may benecessary, commonly to minimize the effects of herniated discs. Withreference to FIGS. 2 and 3, the defect 9 may be in the form of anannular tear, as depicted by the solid black line through the AF, as mayoccur in the course of surgical procedures, injury, or naturaldegradation of the annulus fibrosus. A defect, as used herein, refers toany variation or anomaly from the normal presentation of the annulus,and the term is deemed to include, for example, full or partial tears,full or partial excisions, holes, bulges, degradation, thinning,hyperplasia, or thickening of or in the annulus material. As will bedescribed more fully below, the damage or defect 9 depicted in FIGS. 1,2 and 3 may be repaired in various manners through the practice of thepresent invention, for example as can be seen respectively in FIG. 4, 5,and either of 6 or 7.

In order to repair these defects, whether full or partial, the device ofthe present invention may serve to fill the defect and/or applycompression to the annular wall. Furthermore, the present invention mayserve to reinforce the defect area, thereby preventing furtherherniation. The defect 9 created by a discectomy procedure may fullypenetrate the annulus, extending through to the nucleus propulsus, andforms an opening in the annulus, requiring repair in order to preventthe extraversion of the nucleus.

In some embodiments of the present invention, as shown in FIGS. 5, 6, 7,and 8, the device is intended to apply and maintain a compressive forcebetween the outer and inner aspects of the AF 3 at the point where thedefect or tear 9 exists, thereby serving as a treatment device tofacilitate healing. With reference to FIG. 8, one embodiment of theimplanted device consists of an anchoring element, or footplate 5 placedinternally of the annulus, which is connected to a second footplate 5,placed externally to the annulus, and connected by means of a connectingmember 6. The connecting member may preferably be a suture, filament,thread, fabric, or other flexible member. Alternatively, the connectingmember may be a rigid member capable of resisting the free movement ofassociated anchor elements or sealing members, and intermediarymaterials. The rigid connector element may be capable of resisting anencountered force, and also serve to maintain tension upon the tissuerestrained by the treatment device. The connecting member may bemanufactured from materials known in the art, e.g., synthetic polymers,natural polymers, metal, etc., and may be resorbable or non-resorbable.The footplates 5 may be constructed of a biocompatible material (e.g.,resorbable polymer, resorbable collagen or other resorbable ornon-resorbable material). The footplates as used in the practice of thepresent invention may be arranged to serve as an anchoring means for thedevice, and optionally may serve as a sealing means. The footplates maybe rigid, or somewhat flexible, but in any event, not so flexible as topull through a defect or delivery opening in the AF when implemented, anexample of which is depicted in FIG. 9. The implantable components(e.g., the footplates, sealing members, connecting elements,intermediary components, fastening elements, etc.) of the presentinvention may be manufactured from a variety of biocompatible,resorbable or non-resorbable, materials, examples of which can be foundin a non-exhaustive list supplied as Table 1 below.

As can be seen in FIGS. 9 and 10, the footplates 5 may also containsmall barbs or points 7 to interface with the internal or externalsurface of the AF to aid in securing the device and prevent them frombeing dislodged. It is recognized that footplates may be specificallyshaped for a particular purpose, that is, footplates intended to beinserted into the interior of the annular wall may have a firstorientation, shape, or curvature, while another footplate intended foruse outside of the annular may feature a second orientation, shape orcurvature.

It is also recognized that various arrangements of footplates andconnecting members may be necessary. For example, it might be beneficialto utilize a single footplate on the exterior of the annulus, and placea plurality of footplates in the interior of the annulus, all connectedby at least one connecting member, or alternatively, the arrangement maybe reversed, with a single interior footplate and a plurality ofexterior footplates. It is recognized that the footplates describedabove may additionally feature some application (e.g. coating) of asealing material (to be discussed below) to aid in maintaining annulusintegrity against leakage. The footplates, or other members, may alsocontain a marker, additive, or other material that can be visualizedwith x-ray or other imaging technologies to assist with the placement ofthe device and potentially allow for longer term follow-up of the devicelocation.

In an embodiment of the present invention having a tear in the annularwall, as depicted in FIG. 8, though it is recognized that a partial tearor other defects would behave similarly, there is arranged, between andaffixed to (e.g., glued, knotted, etc.) the footplates 5 (both internaland external) by any means known in the art, an intermediate member 8.The intermediate member may be located at the level of the defect 9 andmay be made from a natural polymer, (e.g., collagen, etc.). In someembodiments of the present invention, the intermediate component mayserve to deliver a therapy (e.g. for the purpose of moderatinginflammatory response, aiding healing, etc.), such as a biologicallyactive agent, examples of which are listed in Table 2. The intermediatecomponent 8 may consist of a flowable or expandable material (e.g.hydrogel, adhesive, packing material, etc.) that serves to aid insealing or adhering the tissue, so as to prevent the flow of materialinto or out of the NP (e.g., loss of NP, or inflow of blood, etc.)through the defect in the AF (e.g. a plug). This may be accomplished byproviding an intermediate component 8 that is able to conform to theshapes and surfaces of the defect. It is recognized that theintermediate component may be delivered as a rigid material that is ableto swell upon being implanted in the body, effectively sealing thedefect from the extravasation of nucleus material. The intermediatemember may additionally feature a natural material that can act as amatrix for cellular infiltration and regeneration of the annulus.

The materials of the present invention that are resorbable may comprisea porous tissue matrix material (PTM). This PTM material will preferablyhave an interconnected porosity, and sized to encourage the invasivegrowth of new cellular material. The interconnected porosity also servesto ensure adequate fluid flow to provide an optimal growth environmentfor the invasive cells. The ingrowth of new cellular material willbeneficially encourage the incorporation of the device material into thenearby tissues, and provide for biomatching or compliance matching,where the device material and components present similar physicalcharacteristics as the original tissue.

In another embodiment, as depicted in FIG. 6, arranged through theannular wall is the connecting member 6, without any intermediate orplugging material. It is recognized the connecting member may itself becoated or treated to aid in healing. For example, the intermediatecomponent may feature a coating or otherwise release (e.g., by naturaldegradation, diffusion, etc.) a therapy (e.g. biologically active agent,drug, etc.), where the therapy may prevent an undesirable response orpromote a beneficial response. In the embodiment shown in FIG. 6, thetension maintained by the placement of the closure device serves torepair the defect, and or allow for healing to occur.

In another embodiment, as depicted in FIG. 7, a footplate 5 may beplaced internally to the annular wall 3, connected to a connectingmember 6, extending through the wall and associated with an externalfootplate or anchor in the form of sealing plug. This footplate maybeneficially be a non-rigid material, however, the physicalcharacteristics of the sealing plug are such that it will not be pulledthrough the annular wall once implanted but may be urged into theannulus (e.g. by the tension applied through the connecting member 6),and may deform to fill the defect, such as may be created through anexcission procedure. For example, the footplate may be a sealing plug ofhydrophilic material which, upon hydration, expands in volume to form athick mass, at least rigid or viscous enough so as to prevent pullthrough, yet deformable enough to adequately seal against the annularwall, thereby preventing the escape of nucleus therethrough.

Referring to FIG. 11, where the defect 9 extends fully through theannular wall, and may be created as a consequence of a full discectomy,the intermediate component 8 is preferably capable of filling the entiredefect void created by the removal of a portion of the annulus. Theintermediate component may be locked in place, and against adjacentwalls of the annulus by an applied pressure created through compressionapplied through the connecting member.

In practicing the present invention for the repair of a partial or fulldefect in the annular wall 3, an access sheath (e.g. a cannula) 13,optionally housing an obturator 14, as depicted in FIG. 12 may beinserted through a percutaneous incision in the external skin andextended through underlying tissue to the AF using techniques known inthe art.

In an embodiment, the access sheath 13 through which any subsequentinstruments or components may be inserted is preferably of a fixedlength. The subsequent instruments which may be directed through thesheath may incorporate that fixed length into their shafts, and extendout the distal end of the sheath by a precisely determinably amount, asthey may be calibrated or have markings, in order to allow the surgeonto determine the depth of penetration into the target tissue (e.g., intothe disc, thickness of the annulus, and zone of nucleus). As the sheathand obturator are directed to the target site, the obturator may beremoved and a trocar or tissue dilator (for example, tissue dilator 18of FIG. 36) is used to initially penetrate into the AF at the zone ofthe defect or tear. A sharp trocar or tissue dilator (which ispreferably calibrated along at least a portion of its length) may beinserted through the access sheath 13 to the surface of the AF at thelocation of the tear and confirmed in some manner (e.g., viaradiography). It is envisioned that multiple increasing diameters and/orlengths of trocars or tissue dilators may be used to gradually open alumen within the AF. The instruments inserted into the living being,(e.g. the sheath, trocar, and obturator, etc.) may feature monitoringelements (e.g., radiopaque markers, bands, penetration markers,orientation markers, calibration, etc.) to allow accurate tracking,placement and implementation of the devices using techniques known inthe art (fluoroscopy, x-ray visualization, etc.). The trocar may then beadvanced into the disc, for example through the AF to the level of theNP. The trocar may then be removed, thereby creating an accessible openlumen within the cannula or access sheath 13, such that the deliverydevice 15 of FIG. 13 containing an embodiment of the treatment device,such as a fastener or closure device may be inserted into and extendthrough the access sheath 13 as depicted in FIG. 14. As shown here, thetreatment device or closure device of FIG. 13 includes a distal anchor5′ attached to a connecting element 6, and a proximal anchor 5″ heredepicted in the form of a material capable of sealing or plugging thedefect upon deployment. In another embodiment, the sealing or pluggingmaterial may be an intermediary component that is located between asecond anchor (not shown) which would be housed within the deliverydevice 15 in a position proximal to the intermediary element, andextended between the proximal anchor, the intermediary material and thedistal anchor would be a connector element arranged to facilitate theapplication of tension upon delivery. As depicted in FIG. 14, thefastener or closure device within the delivery device 15 includes a pairof anchoring elements (5′ and 5″) and a connecting element 6 extendingtherebetween. Also shown is a fastening element or holding mechanism 17which may be, for example, a slip knot that is arranged to secure thedevice and maintain tension after it is applied through connectingmember 6. It is recognized that multiple arrangements of the fastener orclosure device are possible by varying the arrangements, lengths andnumbers of the closure device elements in and around the tissues beingrepaired. That is, multiple anchors 5 may be deployed internal to thenucleus, and multiple connecting elements 6 and optionally intermediarymaterials 8 may be utilized to secure the elements in or around the discand annulus.

FIG. 14 depicts the delivery device 15 within the access sheath 13, andis prepared for being introduced into the disc through percutaneouspuncture, and extended into an aperture created in the AF to the levelof the NP for delivery and implementation of the remaining components ofthe device (e.g. the closure device elements). In an embodiment, thedelivery device 15 may be calibrated along its proximal end relative tothe proximal edge of the access sheath 13 to allow the surgeon todetermine when the anchor element 5′ has traversed a distanceapproximately equal to the thickness of the AF. Alternatively, otherlocation detection mechanisms may be utilized in ensuring accurateplacement of the delivery device for placement of a fastener or closuredevice.

With reference to FIGS. 13 and 14, the delivery device 15 may be shapedor incorporate elements that ensure the device (e.g. anchor, patch,mesh, plug, etc.) once deployed, is unable to be retracted back intoeither the access sheath or the delivery device. For example, in oneembodiment, the anchor may be maintained temporarily in alignment withthe axis of the delivery device, however, once free from the restrainingconfines of the access sheath 13 and/or delivery device 15, the anchors5 will naturally shift to a position that precludes retraction back intoits aligned position. This may be accomplished in various manners, suchthrough the flexibility of the connecting element 6, or alternativelymay rely on a restrictive element (e.g., nitinol fingers or other oneway componentry shaped into the delivery device) that allow passage inone direction but prevents passage in the reverse direction. Thisensures that the anchor 5′ of the closure device is deployed properly onthe first attempt, and prevents the anchor 5′ and the balance of theclosure device from reentering the sheath 13 or device 15, and alsoprevents the entire closure device from being retracted along with theaccess sheath 13 and/or delivery device 15. In this manner, the need forfurther tamping or ejecting mechanisms to ensure the placement of theclosure device is eliminated. Though, especially in the absence of thesefeatures, it is recognized that the present invention may be compatiblewith the use of such tamping or ejecting mechanisms, such as a rodextended down through the delivery device to eject the closure deviceelements.

For example, in order to accomplish the delivery of the device intendedfor use in repairing a full or partial tear 9 in the annular wall 3, forexample as depicted in FIG. 6, 7 or 8, once the delivery device 15 andaccess sheath 13 of FIG. 14 is internal to the AF 3 (within the nucleus4 region), a first footplate 5′ may be deployed, such as through theimplementation of a device or tamping mechanism directed through theinternal bore of the delivery device 15 to deliver (e.g. push) theimplantable device components out of the distal end of the deliverydevice and/or access sheath 13, and contacted against the internalaspect of the AF 4. The location of the footplate 5 or other componentsof the device may be confirmed by imaging as they may be made of, orincorporate a radiopaque material. Subsequently, the connecting member6, and optionally an intermediate component 8, of the device may bedeployed through the aperture to the level of the tear 9. As previouslydescribed, the intermediate component 8 may be made of suitable packingmaterial, e.g., collagen, alginate, etc., and may contain some bioactivesubstance both of which either together or alone act to improve thehealing of the tear. Next, the proximal footplate 5″ and optionallysealing material may be deployed against the outer surface of the AF 3and compression may be applied to the AF through the deployment of aholding mechanism or fastening element 17 (e.g. a slip knot, or othermethod for maintaining tension between the footplates as known in theart) which is drawn thereby against the proximal footplate 5″. Thedeployment of a holding mechanism 17 may be performed with or withoutthe delivery device 15 in place, using techniques known in the art. Itis recognized the act of compression alone may act to facilitate thehealing of the tear, or may act to prevent herniation or leakage of thecontents of the NP through the tear, or prevent further expansion of thetear. The internal coupling mechanism or connector element 6 which maybe made of a bioabsorbable material is then removed or cut at aconvenient location, such as at the surface of the skin.

In this or another embodiment, the use of a means for location detectionmay be beneficial. In FIG. 15 there is shown embodiment of a locatingdevice for effecting the proper positioning of the access sheath 13 orother deliver device within the annulus or nucleus. As can be seen inFIG. 15, the depicted embodiment of a locating device basicallycomprises a conventional obturator 14 providing a passageway 402extending longitudinally down substantially the length of the device,preferably internal to the obturator, although external may be capableof functioning similarly. In the embodiment having an internalpassageway lumen 402, a detection port 404 extends radially inward intothe device communicating with the distal end of the passageway 402,while a proximal port 406 extends radially inward into the devicecommunicating with the proximal end of the passageway 402. The locatingdevice is arranged such that it may be fully inserted within the accesssheath 13 and extend a precise amount beyond the end of the accesssheath, as shown in FIG. 15, and further the proximal port does notenter the proximal end of access sheath 13, thereby ensuring thatproximal port 406 remains accessible or visible to the operator.

The length of the annular passageway 402 is selected so that when theobturator 14 of the locating device shown in FIG. 15 is fully extendedwithin the access sheath 13 and the distal end of the sheath is locatedwithin the interior of the annulus or lumen, the detection port 404 ofthe passageway 402 extends just beyond the free end of the sheath, whilethe entrance port 406 is accessible to the operator. The detection port404 forms a window, which is exposed to the material in the annulus.

In another embodiment of the location detector of FIG. 15, a flexible orreconfigurable member (e.g. a probe)(not shown), may be inserted intoproximal port 406 and extended through the passageway 402, exiting atdetection port 404, such that the flexible probe or member may be usedto probe the tissue, thereby using, for example, tactile feel to locatethe sheath or other insertion member, such that a device maysubsequently be accurately placed.

In another embodiment of the location detector of FIG. 15, a reducedpressure (relative to that of the nucleus material), aspirating force,or vacuum may exist or be applied at proximal port 406, such that thepassageway 402 is under negative pressure or reduced pressure relativeto the pressure of the tissue material at the distal end and detectionport 404. The reduced pressure or aspiration may cause the tissueadjacent to the detection port 404 to be introduced into the passageway402. Continued aspiration may cause the tissue to travel the length ofthe passageway and exit at proximal port 406. In the event that thedetection port 404 is adjacent annular material, the fibrous nature andinherent strength of the annulus will prevent aspiration and/ordetection of material at the proximal port. By contrast, where thetissue adjacent the detection port 404 is a gelatinous or liquidmaterial, the tissue will travel the length of the passageway 402, andbe detectable at the proximal port 406. In this manner, the locatingmeans may thereby serve to indicate the location of the detection window404, allowing the determination of the location of the distal end of theaccess sheath 13, whether it has penetrated into the nucleus or remainsin the annulus. It is recognized that, especially with younger patients,the nucleus material may be capable of freely flowing through such apassageway 402 as described above, while at atmospheric pressures,though as the nucleus material ages or degrades, it tends to become moreviscous, and may resist flowing through such a passageway, therebynecessitating application of a vacuum.

In another embodiment of a location detector, sensors (not shown) may beplaced at or near the distal end, such as within detection port 404 toconfirm accurate placement. Such sensors may be in the form of anoptical sensor or pressure sensor that may be exposed to the tissue orfluid during placement of the device, and generate an indicator signalor other feedback for the operator and enable confirmation of accurateplacement of the device.

Repair of Herniated or Bulging Annulus Fibrosis

An annular defect such as a bulge or herniation may be caused by or bethe result of weakening in the AF secondary to physiologic changes tothe AF or NP, and the AF may weaken and protrude from its normalanatomic space pushed by the internal NP as can be seen in FIG. 16. Inmore severe cases, the AF 3 may rupture and allow extravasation of theNP 4 contents to the surrounding anatomy (as depicted in FIG. 17).Symptoms may arise when the herniation (bulge) or leakage of the NPthrough the defect 9 in the AF 3 impinges on the nerve root 2 or spinalcord 1. There are many therapies currently utilized for treatment of theherniation (bulge) and resultant pain, starting with conservativetherapies such as bed rest and pain medicines, to epidural injections,to open or minimally invasive discectomies or to complete discectomy andfusion of the disc space and adjacent vertebrae. An object of thisinvention is to provide a minimally invasive means to contain leakage orto reduce the bulge or defect 9 created by one of the invasive treatmentmeans in an annulus to prevent impingement on the nerve roots or spinalcanal.

In an embodiment of the device envisioned for the treatment of bulgingor herniated discs, with reference to FIG. 18, the closure deviceconsists of a distal footplate 5′ which is arranged to rest against theexternal aspect of the AF 3 directly opposite the bulge 9 in disc 16 inthe anterior-lateral portion of the AF 3. A connecting element 6traversing through the NP 4, connects the distal footplate 5′ to anotherfootplate, proximal footplate 5″, which is arranged to rest against thebulge 9 in the affected part of the AF 3 in the posterior part of thedisc. The footplates 5′ & 5″, as previously described may be constructedof a resorbable polymer, resorbable collagen or other resorbable ornon-resorbable material. The footplates 5′ and 5″ may be somewhatflexible, but not so much as to pull through the delivery opening ordefect 9 upon the application of compression. The footplates 5′ and 5″may also contain small barbs or points 7 (as can be seen in FIG. 10) tointerface with the internal or external surface of the AF 3 to preventdislodging. Connecting member 6 may preferably be a suture, similar tothat described above, and may be manufactured from polymers known in theart, including synthetic and natural polymers. In some embodiments ofthe device, the connecting member may also be associated with anintermediate component 8, as has been described above. The intermediatecomponent 8 may be arranged within the walls of the annulus 4, as shownin FIG. 11, and/or all or a portion of the NP 4, as shown in FIG. 19.The intermediate component 8 may function to prevent the escape of NPthrough the defects 9 or openings created by the implanting of theclosure device. In an embodiment, the intermediate material 8 may betreated with fibrin glue or other means by which it can stick to theopening or defect 9, or alternatively may serve to deliver at least onetherapy, drug or biologically active agent, such as those listed inTable 2. It is recognized the suture or connecting member 6 itself mayfeature a coating of a sealing material or a therapy that may bedelivered upon implantation in the living being. All of the closuredevice components, including footplates 5, intermediary material 8 andconnecting members 6 may be non-resorbable for permanent implantation,partially resorbable, or completely resorbable, such that a temporaryimplant may be achieved.

It is recognized that there may be advantages to presenting footplates 5of differing dimensions in the device. For example, in the case ofrepairing a herniated disc, there may be benefit to presenting a distalfootplate 5′ opposite the bulge or defect 9 that is greater in surfacearea than a proximal footplate 5″ placed directly against the bulge 9.In this manner, as compression is applied through connecting member 6,the compressive force is distributed over a larger area by distalfootplate 5′, and the corresponding force applied by proximal footplate5″ will accordingly be distributed over a smaller area, resulting inincreased efficiency in minimizing the bulge or defect 9 protrusion.Furthermore, multiple footplates at any end of the closure device may beutilized in order to increase the surface area in a similar manner.

It is also recognized the footplates may be delivered by the deliverydevice to a variety of locations within the intervertebral disc, whereinone or more footplates may be utilized to provide support for anopposing footplate. The location of the footplates may be in a varietyof combinations, including the placement of multiple footplates and/orin multiple locations. For example, one or more of the footplates may beplaced within the nucleus as shown in FIG. 20. In the embodiments havingfootplates placed within the nucleus, they may be relying on theinherent viscosity nucleus propulsus material to provide the necessaryresistance and thereby maintaining tension upon a connecting member 6.It is recognized that the viscosity of the nucleus may be significantlyincreased in aged nucleus material or degraded material. Alternatively,there may be a benefit to placing the footplates within the annularwall, such where the footplates serves to replace a portion of theannulus that has been removed by excission, as shown by the proximalfootplate 5″ of FIG. 21. Most preferably the footplates may be placedagainst the exterior aspect of the annulus as described previously, andas shown with reference to FIG. 19.

It is recognized that various other combinations of footplate placementare possible, varying in location and number. Footplate locations mayvary within a given embodiment, such as is depicted in FIG. 21, having adistal footplate 5′ against an interior aspect of the annulus 3 andwithin the nucleus 4, and having a proximal footplate 5″ inside of theannulus or replacing a portion of the annulus. Additionally, in someembodiments, the placement of multiple footplates may be necessary toprovide the necessary levels of support. Such multiple footplateplacement may be seen in the exemplary embodiment of FIG. 20 wheremultiple distal footplates 5′ are operating in parallel to maintaintension upon connecting members 6 and upon proximal footplate 5″.Alternatively, as can be seen with reference to FIG. 23, additionaldistal footplates 5′ may be placed operating in series with anotherdistal footplate 5′, which is itself further connected to and arrangedto maintain tension upon and a proximal footplate 5″. Furthermore,multiple defect sites may be addressed through the practice of multipleembodiments of the present invention, as can be seen in FIG. 22.

In an alternative embodiment of the device envisioned for the treatmentof bulging or herniated discs, as depicted in FIG. 24, the devicefeatures multiple anchoring members or footplates 5′ which are arrangedto rest against the AF opposite the bulge 9 in disc 16 in theanterior-lateral portion of the AF 3. The placement of multipleanchoring members or footplates as shown herein serve to provideincreased surface area over which to distribute a given load, which willnecessarily be less than the load per unit area imposed by a singlesimilarly sized footplate placed against a bulge or defect 9, therebyovercoming the bulge and restoring the normal appearance of the annulus3.

With reference to FIGS. 18 and 19, depicting the process for repair of adefect 9 in the form of a hernia (bulge). In practicing this embodimentof the present invention for the repair of a herniated disc or bulge ordefect 9 in the annular wall 3, a cannula or access sheath 13 andobturator 14, as described above with reference to repairing a partialor full defect in the annular wall, may be inserted percutaneously anddirected towards the annular wall, preferably towards the defect 9 inthe annulus. As described previously, once the cannula 13 has passedthrough the soft tissue and is resting in the proper location againstthe annulus 3, ideally at the location of the herniation or bulge 9, theobturator 14 is removed and a trocar or tissue dilator 18 may beinserted and may be advanced into and/or through the annulus, therebycreating or expanding an aperture for the insertion of the deliverydevice. Furthermore, and in the case where the footplate 5′ is to berested against the outer aspect of the opposing portion of the AF 3, thetrocar or tissue dilator 18 may be advanced through the opposite AF aswell. The insertion of the trocar may be performed using standardtechniques known in the art. Upon verification of placement of thetrocar completely through the disc 16, such as is possible through theemployment of monitoring features such as detection location features(e.g., calibration of the trocar, radiographic visualization, or othermeans) the delivery device 15 housing the closure device may be insertedthrough the access sheath 13, and through the nucleus 4 space, exitingthe opposite side of the AF.

Once the delivery device has been passed through the AF, NP and oppositeAF the deployment of the fastener device is performed to arrive at theembodiment as depicted in FIGS. 18 and 19 having a distal footplate 5′external to the annulus 3.

Alternatively, the delivery device may remain within the NP and notextended out the opposite AF, and may deploy one or more distalfootplates 5′ against the internal aspect of the AF 3, with the resultas depicted in FIG. 20. Deployment may occur by depositing the closuredevice components into place from the delivery sheath 15, for example,by utilizing a rod or other pushing device directed through the deliverysheath from a proximal location, which upon contacting one or morecomponents of the closure device causes each component to exit thedistal end of the delivery sheath. The location of each component of thedevice may be confirmed by various monitoring mechanisms as known in theart, e.g., radiopaque or other visible markers in combination with x-rayimaging or fluoroscopic imaging, positional markings or bands, etc.

Subsequently, and preferably as the delivery device 15 and/or accesssheath 13 is retracted, the connecting member 6, such as a suture may bedeployed, optionally in conjunction with a soft intermediate component 8of the device, as can be seen in FIG. 19. As previously described, theintermediate component 8 may be made of a polymer material, and may beresorbable (e.g., collagen). Furthermore, the intermediate component maycontain some bioactive substance, therapy, or drug, such as those listedin Table 2. It is recognized that any of the resorbable ornon-resorbable components utilized in the practice of the invention mayalso beneficially delivery a biologically active agent as well, such aspain reducing or inflammatory reducing agents, or other drugs. Theintermediate component 8 including any bioactive substance, eithertogether, or alone, may act to improve the healing of the defect. It isrecognized the intermediate component 8 may be made of a rigid polymersimilar to the footplate 5. Compression may be applied to the AF 3 andthe bulge defect 9 upon removal of the delivery device 15 and/or annularsheath 13 from the disc 16, and deployment of holding mechanism orfastening element 17 (e.g., an automatic slip knot) which when pushedagainst the proximal footplate 5″, or in the case of a rigidintermediary component, the holding element may be pushed against theintermediary component 8, and maintains tension upon the connectingmember 6. This tension results in compression created between footplates5′ and 5″, such that the act of compression alone may act to reduce thebulge defect 9 in the AF 3, thereby relieving or preventing impingementon the nerve root 2 or spinal cord 1, and resulting pain or harm.Additionally, the implanted fastener or closure device may act toprevent subsequent extravasation of the contents of the NP 4 through thebulge or defect 9, and may provide a scaffold, such as may occur if madeof a collagen or other porous material, to support the regeneration ofthe AF. The internal connector or coupling mechanism 6, extending outfrom the disk proximally may then be removed at a convenient location toencourage healing, e.g., such as being severed at the surface of theskin, in order minimizing irritation, inflammatory response andopportunity for infection.

Repair of the Annulus Fibrosis Secondary to Placement of a NucleusPropulsus Implant Material

Newer approaches to the repair of the degenerated intervertebral discand specifically the degenerated NP have envisioned the removal,replacement, and/or augmentation of the natural NP material with anartificial nucleus replacement material designed to mimic the naturalmechanical properties of the NP. In this manner, normal disc functionmay be restored by the insertion of a synthetic or natural materialthrough the annulus and into the nucleus.

As can be seen in FIG. 29, the nucleus replacement implant material 25may be a material capable of being delivered by a delivery apparatus 27(for example, being injected via a needle, cannula or other suitableinstrument, or being placed through a cannula, sheath or other suitableinstrument), into the region of the nucleus 4, either with, or withoutremoving the existing NP. The material 25 may then remain entrapped,either permanently or temporarily, within the annulus 4, and restore thenatural mechanical function of the nucleus propulsus 4. Examples ofmaterials suitable for injecting and serving as a nucleus replacementinclude synthetic or natural hydrogels (e.g., collagen gels, PEC gel,etc.) Alternatively, an injectable implant material 25 may be injectedas a liquid, hydrogel, or paste, and harden or cure in-situ to become aself-supporting implant material 25. This material may serve tosupplement the mechanical properties of the degenerated NP, or in thecase of complete nucleus removal, the implant material would replace theNP and mimic the natural biomechanical and viscoelastic properties ofthe disc.

Alternatively, the nucleus implant material 25 may be a self-supportingmaterial, resilient or otherwise (e.g. solids, porous foam, collapsibleresilient cage, disc or stent structure, etc.), at the time of beingimplanted. There are currently several developmental attempts to addressthis approach, most notably in the form of a device utilizing apartially hydrolyzed polyacrylonitrile housed within a polyethylenejacket (manufactured by Raymedica), and an implant utilizing Aquacryl 90which is a modified poly-acrylonitrile (PAN) that can take up to 90% ofits weight in water (manufactured by Replication Medical). This materialis bonded to internal Dacron meshes and is partially hydrated and uponinsertion provides anisotropic axial expansion

The self-supporting implant material 25 utilized in this embodiment ofthe present invention may be provided in various shapes or conformations(e.g., collapsed, preshaped to a particular portion of the disc or theentire disc, etc.). The implant material 25 may be implanted in a firstconformation, and following implantation take on a second conformation,for example, a collapsible implant may expand after being placed withinthe nucleus due to physical means or rehydration, and arrive at a secondconformation due to the anisotropic properties of the material.

In the practice of the technique of NP replacement or augmentation, theintegrity of the natural AF 3 would necessarily be compromised to allowthe insertion of the implant material. For example, in order tofacilitate delivery of the NP filling implant material 25, and in thecase of an injectable implant material 25, a delivery apparatus 27 inthe form of a needle may be directed through the soft tissue to theouter level of the AF 3, then through the AF and into the nucleus 4 inorder to deliver the implant material 25. The delivery apparatus 27 uponpenetrating through the AF, may be directed through an existing defect,or alternatively may create a defect 9, which may or may not requirerepair through the techniques described herein. It is also a techniquethat a cannula/obturator may be a suitable delivery apparatus 27 for anucleus replacement implant material 25, and may be inserted to thelevel of the AF 3, an opening created either through the placement ofmultiple trocars through the AF or alternatively through the use of acoring/cutting tool to create a lumen in the AF for the removal of theNP and subsequently for the injection of the material. Alternatively,for a solid implant material 25, an opening in the AF must be created toallow the removal of the degenerated NP and insertion of the implantmaterial. In order to implant solid or self-supporting devices whosesize is at or near that required to fill the nuclear space 4, arelatively large opening or defect 9 must be utilized or created in theAF 3 to allow removal of the NP material and insertion of theself-supporting implant material 25. If left un-repaired, there havebeen reports in the literature of expulsion of such devices. It isrecognized that a collapsible or deformable self-supporting implant mayserve to minimize the opening required to implant the device. In anyevent, it is desirable to contemplate the filling and repair of thedefect 9 in the AF 3 to reduce the risk of expulsion of the implantmaterial 25 and to support the repair and regeneration of the AF.Furthermore, in order to prevent potential extravasation of the fillingmaterial 25 after implantation, and to reinforce the mechanicalintegrity of the AF 3 or to potentially regenerate the AF, a fastener orclosure device of the present invention may be utilized to ensure thatthe opening created in the AF to deliver the NP filling material isclosed, as can be seen with reference to FIG. 11, where the nucleus 4would be replaced with an implant material (not shown). The implantmaterials 25 contemplated may utilize natural matricies, which canfacilitate or enhance the in-growth of cells and tissue and ultimatelyfacilitate the regeneration of the AF, providing a more naturalconstruct.

Following the implantation of the artificial NP implant material 25(whether injectable or self-supporting), the fastener or closure deviceof the present invention may be directed through the same access openingin the annulus through which the injection or insertion occurred, toseal the opening or defect 9. This repair may occur in a substantiallysimilar manner as has been described with reference to any of thetechniques described above for repairing a defect in the annulus,particularly the techniques described to treat the defect remaining in adiscectomy procedure. These techniques are particularly well suited forrepairing defects that are created through the use of injectable nucleusreplacement materials. Especially in the case of NP repair orreplacement with a solid implant, there may be a need to repair a muchlarger breach in the AF. This may be accomplished using the presentinvention to insert a device as depicted in FIGS. 25 and 26, 27, and 28,which are discussed below.

The embodiment of the device depicted in FIG. 25 features a plurality offootplates 5, positioned to prevent the free movement of the closuredevice, and preferably arranged at the extremities of the implant.Arranged between footplates 5, is at least one connecting member 6 ashas already been described. The connecting member 6 may be a singlefilament that is threaded or extended between each of the footplates 5of the device. Alternatively, multiple connecting members 6 may beutilized between a pair or more footplates 5. It is also recognized thatseveral connecting members 6 may be arranged between each footplate 5,fastened together (e.g., knotted, etc.) using techniques known in theart, effectively forming a web of connecting members 6.

Also arranged between the footplates 5, and associated with the at leastone connecting member 6 is an intermediate component 8 as shown in FIG.25. This intermediate component 8 may be of similar material andconstruction to previous embodiments having already been described.

As depicted in FIGS. 26, 27, and 28, the intermediate component 8 may beutilized to supplement or replace a substantial portion of the AF 3, andmay be in the form of a sheet of material arranged to replace or repairthe portion of the AF that has been damaged, for example, in theinsertion of a solid NP replacement implant. The sheet of material maybe a resorbable polymer for temporary augmentation or repair of the AFor a resorbable sheet matrix with porosity to allow cellularinfiltration and potentially facilitate the regeneration of the AF.Alternatively, the sheet of material may be non-resorbable to effectuatea permanent repair to the AF.

In the practice of the present invention as depicted in FIGS. 26, 27,and 28, access to the NP may be achieved using techniques similar tothose described elsewhere in this specification, for example, utilizingany or all of a cannula, obturator, tissue dilator, trocar, accesssheath, guidewire or other described components. The deployment of thefastener device to effectuate the repair of the AF may be performedsimilarly to the repair of a tear or defect in the annulus.Additionally, as depicted in FIG. 26 showing the present inventionhaving an intermediate member 8 in the form of a reinforcing band, adistal footplate 5′ may be placed initially against the exterior of theAF or embedded within the AF. The placement of the initial footplate 5′may be performed in a manner similar to the placement of a subsequentadditional anchor, here depicted as proximal footplate 5″, as depictedin FIG. 27. As depicted, access to the interior of the disc may beachieved by entering directly through a central opening created in theAF, such as may be created through the introduction of NP replacementmaterial, injury or other defect in the AF. Subsequently, and now fromwithin the disc, the access sheath and or the delivery device housingthe fastener device is extended through the AF at a separate point fromthe entry location, and towards the exterior of the disc. Thereupon afirst anchor 5′ may be deployed, either at a point where the anchor maybe deployed internal to the AF, or preferably externally to the AF, suchthat the anchor may become lodged against the exterior of the AF uponthe application of tension or other force. By repeatedly directing theaccess sheath and/or delivery device through the AF from within, anddeploying subsequent anchors or footplates 5′ or 5″, the delivery of allof the anchors needed for a particular device embodiment may bepossible. By directing the access sheath and/or delivery device to placeanchors in a pattern into tissue surrounding the central opening throughwhich the trocar originally entered the disc, it may be possible toestablish a perimeter to which the interconnecting members 6 and/orintermediate material 8 (e.g. a band or sheet) may be deployed astension is applied to the connecting member 6 (e.g. a suture) arrangedbetween each of the anchors 5 and optionally associated with theintermediate material 8. Subsequent to placing all of the anchors neededfor a particular device, the access sheath and delivery device may bewithdrawn from the central opening. The connecting member preferably isleft with an end extending out from the disc, such that tension may beapplied, as depicted in FIG. 28 to lodge the anchors in place, andextend the intermediate material, such as a band or sheet, within thedisc. As described previously, a holding mechanism or fastener element17, such as a slipknot, or locking button, lock washer, or other devicethat may be employed to maintain tension upon the device. It is alsopossible that the intermediate material (e.g., as previously described,and may preferably, in this embodiment include a flexible barrier, mesh,sheet, etc.) can be secured in position with footplates or otheranchoring elements (e.g. sutures, staples, glues, etc.) that are securedat other locations not shown in FIGS. 26, 27, and 29.

Description of an Exemplary Procedure for Repair of a Defect in the AFUsing the Device of the Present Invention

With reference to FIG. 30, there is depicted a typical defect 9 in avertebral disc 16, here shown as a full tear in the annulus 3. In thepractice of the present invention, various techniques known in the artmay be utilized for the introduction of the closure device through adelivery device in order to repair such a tear in the annulus. Thefollowing description of one delivery technique is for example only, andis not intended to limit the inventor to only this practice, as othersimilar or equivalent delivery techniques are available and known in theart, and the practice of the present invention through these equivalentprocedures is inherent within the description.

As depicted in FIG. 31, an access cannula 13 (e.g. a needle) may bepositioned through a defect 9, and extend into the interior of theannulus (i.e. the nucleus propulsus) using standard techniques known inthe art, preferably radiographic techniques (e.g. x-ray). As shown inthe exploded view of FIG. 32, the cannula 13 may initially have anobturator 14 as shown, which may serve to prevent tissue from enteringinto the central lumen of the cannula while it is being directed throughtissue. Upon insertion of the cannula 13 into the interior of the disc16, the obturator 14 may be removed, leaving an empty lumen in thecannula 13 for the introduction of the delivery device, as will bediscussed. Alternatively a guidewire 12 or other wire-like element maybe introduced into the cannula (as can be seen in exploded form in FIG.33, and in place in FIG. 34. The guidewire will allow the replacement ofthe first inserted cannula or access sheath 13, to be replaced withanother access sheath (to be discussed) that is to be advanced along theplaced guidewire 12.

With reference to FIG. 35, after removal of either or both of theobturator 14 (from FIG. 32) or the cannula 13 (from FIG. 34), theguidewire 12 or wire-like element can be left in the puncture or defect9 and may serve to guide an access sheath 13 for the delivery system 15to the appropriate position at the target site. As depicted in FIG. 36,the access sheath 13 may optionally utilize at least one tissue dilator18 (e.g. trocar, obturator, etc.) that is arranged to expand the initialopening or defect 9 in the annulus 3 to a size capable of allowing thepenetration of the access sheath 13, and associated delivery devicehousing a closure device into the opening created. It is recognized thata series of tissue dilators 18 and or access sheaths, increasing in sizemay be utilized to achieve an aperture of greater size in the toughannulus layer 3 than the original opening or defect 9 created in FIG.31. In use, the tissue dilator 18 is inserted through the access sheath13, and extends therefrom, forming a tapered snout that serves to expandthe tissue, such as annulus 3 to the point where the access sheath 13may be inserted.

As the access sheath 13 is positioned over the guidewire 12 and advancedinto the aperture, as seen in FIG. 36, various techniques for ensuringthe positioning of the device are available. For example, radiopaquemarkers (not shown) can be used to properly locate the sheath at theideal position. Alternatively, other location detector mechanisms, asdescribed previously, may be utilized.

In the embodiment where an access sheath 13 incorporates an expandableor reconfigurable locking member 22 located at or near the distal end ofthe access sheath 13, the locking member 22 may also function as alocation detector. In this manner, the actuation of the expandable orreconfigurable locking member may provide feedback or tactile sensationsto the operator as to the type of tissue is being encountered, therebyallowing the operator to distinguish placement within the annulus 3 fromplacement within the nucleus 4. For the practice of this embodiment, itis preferred that the tissue dilator 18 and wire 12 be removed, asdepicted in FIG. 37, leaving the access sheath 13 penetrating into thedisc 16.

As shown in FIG. 38, the realization of location detection may beachieved by deploying or reconfiguring the locking mechanism 22, by suchas through the action of actuation mechanism 23. The actuation of theexpandable or reconfigurable locking member 22 may be accomplished byvarious means (e.g. inflation, or mechanical actuation). As shown inFIG. 38, with this particular embodiment, actuation mechanism 23 ispreferably located at the proximal end of the access sheath 13, and maybe rotatable, and upon rotation, or in the case of an inflation port,upon delivery of an inflation charge, serves to actuate the lockingmember 22 at the distal tip of the sheath 13, causing the locking member22 to expand via one of several mechanisms (e.g. balloon expansion,nitinol wings, etc.). In the instance where the actuation of the lockingmember 22 were to cause the locking member to encounter tough annulustissue, this would serve as an indicator to the operator that the sheathmust be advanced into the nucleus, until softer nucleus material isencountered, allowing easier expansion of the locking member 22. Themechanisms (e.g. balloon, nitinol wings, etc.) may also be used toprepare a physical space for the delivery of the device. For example,the balloon can be inflated to a large initial diameter to stretch orotherwise move tissue. Then the balloon can later be reduced in size toprovide a deployment space for a component of the device. In the case ofan embodiment having another expandable mechanism, such as nitinolwings, the expandable mechanism may be expanded and optionally throughthe rotation or translation of the access sheath, or other instrumentupon which the mechanisms are mounted, a physical space can be createdto allow for proper deployment of the remaining components of thedevice.

Upon successful deployment of the locking member 22, and with referenceto FIG. 39, the operator or surgeon may retract the access sheath 13until resistance is felt as the locking member 22 traverses relativelyfreely through a portion of the nucleus 4 and encounters the annulus 3thereby providing the resistance to further retraction. Optionally, andas shown in FIG. 40, a locking mechanism (e.g. a locking ring) 24 may beadvanced down the access sheath 13 in a proximal to distal fashiontoward the puncture (i.e., against the skin or tissue of the patient) tostabilize the access sheath 13.

As shown in FIG. 41, the delivery device 15 containing the closuredevice may now be inserted into the access sheath 13. In a preferredembodiment, the anchoring element 5 is at the distal end of the deliverydevice 15, and is temporarily maintained in alignment with the axis ofthe access sheath 13 to allow passage into the sheath. For example, theanchoring element may be affixed to a flexible connector element 6 (e.g.a filament, suture, etc.), wherein the flexible connector element allowsthe anchoring element 5 to freely conform to varying angles. As shownhere, the delivery device 15 is arranged to be inserted through theaccess sheath 13, and advanced through the sheath until the deliverydevice is fully inserted.

As shown by FIG. 42, upon full insertion of the delivery device 15 intothe access sheath 13, the anchoring element 5 or elements, are deployedinto the nucleus 4. Once free from being aligned with the axis of theaccess sheath 13, the anchor element 5 is able to recover to itsoriginal orientation or another orientation by pivoting at leastslightly on the flexible connector element 6. Furthermore, additionalmechanisms can be used to ensure the anchor element is deployed in sucha manner that retraction into the introducer sheath 13 will not occur.For example, the incorporation of one-way valves located at the distalend of the access sheath 13, or alternatively small nitinol deflectionfingers that would force the anchor element 5 off to the side, may beutilized to prevent the anchoring element from being retracted back intothe access sheath 13.

Also with reference to FIG. 42, a locking tab may be incorporated ontothe proximal end of the delivery device 15. As the delivery device 15 isfully inserted, the locking tab encounters and passes the proximal endof the access sheath 13, traveling in a proximal to distal direction.

As shown in FIG. 43, the locking tab 26 is capable of one-way movementover the access sheath's 13 proximal end, and will then become engagedwith the access sheath as the delivery device 15 is retracted at leastpartially from the patient and out of the access sheath 13. Thisretraction causes the locking tab 26 to engage or lock onto the accesssheath 13, such that the access sheath and the delivery device are nowinterlocked as one unit. While interlocked and one unit, the anchor 5may be placed under tension by the flexible connector element 6 as theanchor encounters the locking member 22 in an expanded state.Alternatively, and as shown in FIG. 44, the locking member 22 mayde-actuated, such as through the action of actuation mechanism 23, suchthat it reverts back to its original, non-expanded state.

As shown in FIG. 45, the access sheath 13 and delivery device 15 areremoved as one unit. The retraction of the delivery device placestension upon the anchoring element 5 through the flexible connectorelement 6. This tension causes the anchoring element to position itselfagainst the interior surface of the annulus 3 at the location of thedefect 9 or aperture. Various embodiments of a closure device can beutilized in the practice of this invention, as have already beendescribed. As depicted in FIG. 45, an intermediate component 8 in theform of a sealing material associated with a portion of the flexibleconnecter element 6 may be deposited within the annulus wall 3.Continued retraction of the access sheath 13 and delivery device 15results in the deployment of a second anchoring element 5″. By alteringcharacteristics necessary for the various embodiments of the closuredevice, such as manipulating the length of the connector element 6, andvarying the placements of the access sheath 13, the deployment of thevarious described embodiments of the closure device can be achieved.

As shown in FIG. 46, the proximal end of the flexible connector element6 or suture is preferably stored within the delivery device 15, forexample, in a coil like system, and self-deploys from the deliverydevice as the device is withdrawn from the puncture, all the whilemaintaining tension upon the originally deployed anchoring element 5. Ascan be seen in FIG. 46, the tension may be maintained through theconnector element 6 by the retraction of the delivery device 15.Further, a tamper or other instrument, may be utilized to push down upona second (proximal) anchoring element 5″, and enable the placement of afastening or holding element 17.

As shown in FIG. 47, a fastening element 17 may be positioned againstthe outside of the puncture in the annulus 3, or preferably against theproximal anchor 5″. Alternatively, the fastening element 17 may beplaced outside of the patient and against the skin where the connectorelement enters the tissue. The fastening element could be any of avariety of tension maintaining devices, for example, a locking washer, aknot, or a variety of elements or combination of elements may beutilized. In this embodiment, a small-elongated tube may be used toposition the fastening element 17 against the closure device and thetube is preferably removed after securing the fastening element 17.Alternatively, a pulley configuration could be used with a fasteningelement 17 in the form of a sliding locking knot, and would not requirethe use of an elongated tube to apply tension, as the operator appliestension simply by pulling on the connector element 6, whereby the pulleyarrangement and sliding locking knot are arranged to maintain thattension.

After the closure device is fully positioned at the tissue defect 9, anyextraneous connector element 6 or suture may be removed. As appropriateany of the embodiments of the device described in the specification maybe used to deliver various medications at the puncture site and to thesurrounding tissues.

Thus since the invention disclosed herein may be embodied in otherspecific forms without departing from the spirit or generalcharacteristics thereof, some of which forms have been indicated, theembodiments described herein are to be considered in all respectsillustrative and not restrictive, by applying current or futureknowledge. The scope of the invention is to be indicated by the appendedclaims, rather than by the foregoing description, and all changes whichcome within the meaning and range of equivalency of the claims areintended to be embraced therein. TABLE 1 Examples Of Suitable MaterialsAliphatic polyesters Bioglass Cellulose Chitin Collagen   Types 1 to 20  Native fibrous   Soluble   Reconstituted fibrous   Recombinant derivedCopolymers of glycolide Copolymers of lactide Elastin FibrinGlycolide/l-lactide copolymers (PGA/PLLA) Glycolide/trimethylenecarbonate copolymers (PGA/TMC) Hydrogel Lactide/tetramethylglycolidecopolymers Lactide/trimethylene carbonate copolymersLactide/ε-caprolactone copolymers Lactide/σ-valerolactone copolymersL-lactide/dl-lactide copolymers Methyl methacrylate-N-vinyl pyrrolidonecopolymers Modified proteins Nylon-2 PHBA/γ-hydroxyvalerate copolymers(PHBA/HVA) PLA/polyethylene oxide copolymers PLA-polyethylene oxide(PELA) Poly (amino acids) Poly (trimethylene carbonates) Polyhydroxyalkanoate polymers (PHA) Poly(alklyene oxalates) Poly(butylenediglycolate) Poly(hydroxy butyrate) (PHB) Poly(n-vinyl pyrrolidone)Poly(ortho esters) Polyalkyl-2-cyanoacrylates PolyanhydridesPolycyanoacrylates Polydepsipeptides Polydihydropyrans Poly-dl-lactide(PDLLA) Polyesteramides Polyesters of oxalic acid Polyethylene GlycolPolyethylene Oxide Polyglycan Esters Poly(Glycerol Sebacate)Polyglycolide (PGA) Polyiminocarbonates Polylactides (PLA)Poly-l-lactide (PLLA) Polyorthoesters Poly-p-dioxanone (PDO)Polypeptides Polyphosphazenes Polysaccharides Polyurethanes (PU)Polyvinyl alcohol (PVA) Poly-β-hydroxypropionate (PHPA)Poly-β-hydroxybutyrate (PBA) Poly-σ-valerolactone Poly-β-alkanoic acidsPoly-β-malic acid (PMLA) Poly-ε-caprolactone (PCL) Pseudo-Poly(AminoAcids) Starch Trimethylene carbonate (TMC) Tyrosine based polymersAlginate Bone allograft or autograft Bone Chips Calcium CalciumPhosphate Calcium Sulfate Ceramics Chitosan Cyanoacrylate CollagenDacron Demineralized bone Elastin Fibrin Gelatin Glass GoldGlycosaminoglycans Hydrogels Hydroxy apatite Hydroxyethyl methacrylateHyaluronic Acid Liposomes Mesenchymal cells Nitinol Osteoblasts Oxidizedregenerated cellulose Phosphate glasses Polyethylene glycol PolyesterPolysaccharides Polyvinyl alcohol Platelets, blood cells RadiopacifiersSalts Silicone Silk Steel (e.g. Stainless Steel) Synthetic polymersThrombin Titanium Tricalcium phosphate

TABLE 2 Examples of Biologically Active Agents Adenovirus with orwithout genetic material Alcohol Amino Acids   L-Arginine Angiogenicagents Angiotensin Converting Enzyme Inhibitors (ACE inhibitors)Angiotensin II antagonists Anti-angiogenic agents Antiarrhythmics  Amiodarone   Lidocaine   Sotalol   Procainamide   DiltiazemAnti-bacterial agents Antibiotics   Erythromycin   Penicillin   Imipenem  Zosyn   Cipro   Flagyl   Vancomycin Anti-coagulants   Heparin  Lovenox Anti-Fungals Anti-growth factors Anti-inflammatory agents  Dexamethasone   Prednisone   Aspirin   Hydrocortisone AntioxidantsAnti-platelet agents   Forskolin   GP IIb-IIIa inhibitors   eptifibatideAnti-proliferation agents   Rho Kinase Inhibitors  (+)-trans-4-(1-aminoethyl)-1-(4-pyridylcarbamoyl)   cyclohexaneAnti-rejection agents Anti-restenosis agents   Adenosine A_(2A) receptoragonists   Rapamycin Antisense Anti-thrombogenic agents   Argatroban  Fondaparinux   Hirudin   GP IIb/IIIa inhibitors Anti-TNF Anti-viraldrugs Arteriogenesis agents   acidic fibroblast growth factor (aFGF)  angiogenin   angiotropin   basic fibroblast growth factor (bFGF)  Bone morphogenic proteins (BMP)   epidermal growth factor (EGF)  fibrin   granulocyte-macrophage colony stimulating factor     (GM-CSF)  hepatocyte growth factor (HGF)   HIF-1   Indian hedgehog (Inh)  insulin growth factor-1 (IGF-1)   interleukin-8 (IL-8)   MAC-1  nicotinamide   platelet-derived endothelial cell growth factor(PD-ECGF)   platelet-derived growth factor (PDGF)   transforming growthfactors alpha & beta     (TGF-.alpha., TGF-beta.)   tumor necrosisfactor alpha (TNF-.alpha.)   vascular endothelial growth factor (VEGF)  vascular permeability factor (VPF) Bacteria Beta blocker Bloodclotting factor Bone morphogenic proteins (BMP) Calcium channel blockersCarcinogens Cells   Stem cells   Bone Marrow   Blood cells   Fat Cells  Muscle Cells   Umbilical cord cells Chemotherapeutic agents   5-FU  Ceramide   Cisplatin   Cyclophosphamide   Doxorubicin   Flutamide  Imatinib   Levamisole   Methotrexate   Mitomycin   Oxaliplatin  Paclitaxel   Tamoxifen   Taxol   Topotecan   Vinblastine Cholesterolreducers Chondroitin Clopidegrel (e.g., plavix) Collagen InhibitorsColony stimulating factors Coumadin Cytokines prostaglandins DentinEtretinate Genetic material Glucosamine Glycosaminoglycans GP IIb/IIIainhibitors   L-703,081 Granulocyte-macrophage colony stimulating factor(GM-CSF) Growth factor antagonists or inhibitors Growth factors  Autologous Growth Factors   Bovine derived cytokines   CartilageDerived Growth Factor (CDGF)   Endothelial Cell Growth Factor (ECGF)  Epidermal growth factor (EGF)   Fibroblast Growth Factors (FGF)  Hepatocyte growth factor (HGF)   Insulin-like Growth Factors (e.g.IGF-I)   Nerve growth factor (NGF)   Platelet Derived Growth Factor(PDGF)   Recombinant NGF (rhNGF)   Tissue necrosis factor (TNF)   Tissuederived cytokines   Transforming growth factors alpha (TGF-alpha)  Transforming growth factors beta (TGF-beta)   Vascular EndothelialGrowth Factor (VEGF)   Vascular permeability factor (VPF)   Acidicfibroblast growth factor (aFGF)   Basic fibroblast growth factor (bFGF)  Epidermal growth factor (EGF)   Hepatocyte growth factor (HGF)  Insulin growth factor-1 (IGF-1)   Platelet-derived endothelial cellgrowth factor (PD-ECGF)   Tumor necrosis factor alpha (TNF-.alpha.)Growth hormones Heparin sulfate proteoglycan HMC-CoA reductaseinhibitors (statins) Hormones   Erythropoietin ImmoxidalImmunosuppressant agents Immune modulator agents Inflammatory mediatorInsulin Interleukins Interlukins   Interlukin-8 (IL-8) Lipid loweringagents Lipo-proteins Low-molecular weight heparin Lymphocites LysineMAC-1 Methylation inhibitors Morphogens   Bone morphogenic proteins(BMPs) Nitric oxide (NO) Nucleotides Peptides Polyphenol PR39 ProteinsProstaglandins Proteoglycans   Perlecan Radioactive materials   Iodine -125   Iodine - 131   Iridium - 192   Palladium 103 Radio-pharmaceuticalsSecondary Messengers   Ceramide Signal Transduction Factors SignalingProteins Somatomedins Statins Stem Cells Steroids Sulfonyl ThrombinThrombin inhibitor Thrombolytics Ticlid Tumor necrosis factor Tyrosinekinase Inhibitors   ST638   AG-17 Vasodilator   Histamine   Forskolin  Nitroglycerin Vitamins   E   C Yeast Ziyphi fructus

1. A system for repairing a defect or opening in the wall of the annulusof a living being, said system comprising an access sheath arranged tobe placed through the opening, a location detector and a treatmentdevice, said location detector being arranged for providing a signalindicative of the location of the system relative to the opening, saidtreatment device being arranged to be positioned at said location torepair said defect or opening.
 2. The system of claim 1, wherein saidtreatment device comprises at least one anchoring member, and aconnector element.
 3. The system of claim 2, wherein said at least oneanchoring device comprises a sealing member.
 4. The system of claim 2,wherein said treatment device further comprises a sealing member.
 5. Thesystem of claim 2, wherein said sealing member prevent the passage of afluid through said defect or opening.
 6. The system of claim 2, whereinsaid connector element comprises a resorbable suture.
 7. The system ofclaim 2, wherein said treatment device further comprises an intermediarycomponent associated with said connector element.
 8. The system of claim7, wherein said intermediary component comprises a collagen plug.
 9. Thesystem of claim 2, wherein said treatment device further comprises alocking member.
 10. The system of claim 9, wherein said locking memberis arranged to maintain said connector element in tension.
 11. Thesystem of claim 1, wherein said system additionally comprises a deliverydevice arranged to be inserted through said access sheath.
 12. Thesystem of claim 11, wherein said delivery device is arranged to housesaid treatment device.
 13. The system of claim 12, wherein said locationdetector is arranged integrally to said delivery device.
 14. The systemof claim 13, wherein said location detector comprises a plurality ofgraduated markings on a proximal end of said delivery device.
 15. Thesystem of claim 1, wherein said location detector comprises a separatedetector passageway lumen through said access sheath.
 16. The system ofclaim 15, wherein a detection probe is directed through said saiddetector passageway lumen and exits said access sheath at a distal end,wherein said probe contacts adjacent tissue.
 17. The system of claim 13,wherein said location detector comprises an electronic sensor thatsenses an adjacent tissue at a distal end of said delivery device, saidelectrical sensor selected from the group consisting of optical sensorand pressure sensor.
 18. The system of claim 13, wherein said locationdetector comprises a reconfigurable member.
 19. The system of claim 18,wherein said reconfigurable member is inserted in a first configuration,and upon actuation is reconfigured to a second configuration.
 20. Thesystem of claim 19, wherein said reconfigurable member is selected fromthe group consiting of; balloon, wing, and finger.
 21. The system ofclaim 13, wherein said location detector is arranged to function as alocking member.
 22. The system of claim 21, wherein said locking memberis arranged to prevent movement of said delivery device from saiddesired location.
 23. The system of claim 13, wherein said locationdetector provides said perceptible signal by a tactile sensation. 24.The system of claim 13, wherein said location detector is arranged todistinguish between deployment of said treatment device within anannulus, or within a nucleus of an intervertebral disc.
 25. The systemof claim 2, wherein said at least one anchor comprises a proximal anchorand a distal anchor, being connected by said filament.
 26. The system ofclaim 25, wherein said proximal anchor is arranged to be delivered to anoutside aspect of an annulus, and said distal anchor is arranged to bedelivered to an inside aspect of said annulus.
 27. The system of claim1, wherein at least a portion of said treatment device is resorbable.28. The system of claim 27, wherein said resorbable material is arrangedto deliver a biologically active agent.
 29. The system of claim 27,wherein said resorbable treatment device comprises a porous tissuematrix material.
 30. The system of claim 29, wherein said porous tissuematrix material is arranged to induce cellular ingrowth.
 31. The systemof claim 9, wherein said locking member is selected from the groupconsisting of a button, knot, and washer.